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Examples of ethnicity and geography issues in global clinical trials ...

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Ethnicity <strong>and</strong> <strong>geography</strong> <strong>issues</strong><br />

<strong>in</strong> <strong>global</strong> cl<strong>in</strong>ical <strong>trials</strong> <strong>of</strong> ACS <strong>and</strong> AF<br />

• Play <strong>of</strong> chance – correction for multiplicity, small patient<br />

numbers <strong>in</strong> geographical subgroups<br />

• Problems with study performance <strong>and</strong> procedures <strong>in</strong><br />

specific geographical area<br />

• Differences <strong>in</strong> compliance<br />

• Differences <strong>in</strong> patient characteristics, co-morbidities,<br />

medical treatments might modulate the treatment effect<br />

• Differences <strong>in</strong> pharmacogenetics, response genetics<br />

• Seldom biological rationale for geographical differences

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